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Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy (PROLONG)

Primary Purpose

Leukaemia, Lymphocytic, Chronic

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ofatumumab

Observation

About this trial

This is an interventional treatment trial for Leukaemia, Lymphocytic, Chronic focused on measuring maintenance therapy, anti-CD20 monoclonal antibody, ofatumumab

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines (Hallek, 2008)
At least PR according to the revised 2008 NCI-WG CLL criteria, within 3 months of the response assessment after the last dose of 2nd/3rd line treatment
The anti-leukemic treatment before study entry should have been at least 3 months or 3 cycles
ECOG Performance Status of 0-2
Signed written informed consent prior to performing any study-specific procedures

Exclusion Criteria:

Known primary or secondary fludarabine-refractory subjects, defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months
Prior maintenance therapy
Known transformation of CLL (eg.Richter's transformation), prolymphocytic leukemia (PLL), or CNS involvement of CLL
Active Autoimmune hemolytic anemia (AIHA) requiring treatment except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
Previous autologous or allogeneic stem cell transplantation
Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis B or C
Other past or current malignancy (with the exception of basal cell carcinoma or the skin or in situ carcinoma of the cervix or breasts) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of exta systoles or minor conduction abnormalities except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data
History of significant cerebrovascular disease or event with symptoms or sequelae
Significant concurrent, uncontrolled medical condition that in the opinion of the investigator or GSK medical monitor contraindicates participation in this study
Other anti-leukemic use of medications including glucocorticoids
Known HIV positive
Screening laboratory values: platelets <50 x 10x9/L, neutrophils<1.0 x 10x9/L, Creatinine > 1.5 X upper normal limit (unless normal creatinine clearance), total bilirubin >1.5 X upper normal limit, ALT >2.5 X upper normal limit (unless due to liver involvement of CLL), alkaline phosphase > 2.5 X upper normal limit
Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor contraindicates study participation
Subjects who have received treatment with any non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication or currently participating in any other interventional clinical study
Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap plus spermicidal agent).

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ARM A: Ofatumumab

ARM B: Observation and assessments as per Arm A

Arm Description

300 mg IV Week 1 followed by 1000 mg IV Week 2 1000 mg IV (a dose every 8 weeks for up to 2 years following the first 1000 mg dose)

Disease status assessments to determine subject response or progression performed approximately every 8 weeks for up to 2 years for both arms according to IWCLL criteria

Outcomes

Primary Outcome Measures

Progression-free Survival, as Assessed by the Investigator

Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the investigator according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.

Progression-free Survival, as Assessed by the Independent Review Committee (IRC)

Progression-free survival is defined as the time from randomization to the date of disease progression (PD) or death due to any cause. PD was determined by the IRC according to the definitions of response in the International Workshop for Chronic Lymphocytic Leukemia (IWCLL) updated National Cancer Institute-Sponsored Working Group (NCI-WG) guidelines. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter; transformation to a more aggressive histology, or occurrence of cytopenia attributable to chronic lymphocytic leukemia.

Secondary Outcome Measures

Overall Survival

Overall survival is defined as time from randomization to date of death.

Number of Participants With Improvement in Response From Baseline

Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.

Time to Next Therapy

Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.

Progression-free Survival After Next-line Therapy

Progression-free survival after next-line therapy is defined as the time from randomization until progression or death following the next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy and who did not have progression or death after next-line therapy were censored at their last date of contact. Participant who died prior to next-line therapy, was counted as an event.

Time to Progression After Next-line Therapy

Time to progression after next-line therapy is defined as the time from progression following randomization until progression or death following next-line therapy and counted as events deaths prior to next-line therapy. Participants who received next-line therapy with a PD prior to receiving next line therapy and who did not had progression or death after next-line therapy were censored at their last date of contact. If a participant died prior to next-line therapy, this was counted as an event.

Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)

The EORTC QLQ-CLL16 is comprised of 16 questions that address 5 domains of health-related quality of life (HRQoL) important in CLL. There are 4 multi-item scales - fatigue (2 items), treatment side effects ([TSE], 4 items), disease symptoms (disease effects scale [DES], 4 items), and infection (4 items) - and single-item scales (social activities [Social Problems (SP) Scale] and future health worries [Future Health (FH) Scale]). These are measured on a four-point Likert scale, where 1 = not at all and 4 = very much. These scores are transformed to give a rating from 0 - 100, where 0 = no symptoms or problems and 100 = severe symptoms or problems. Changes from Baseline were analyzed by a mixed model-repeated measures analysis of covariance (ANCOVA).

Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score

The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: physical functioning (5 items), role functioning (2 items), emotional functioning (4 items), cognitive functioning (2 items), social functioning (2 items), pain (2 items), fatigue (3 items), nausea and vomiting (2 items), five single-item symptom scores (insomnia, loss of appetite, constipation, diarrhea, and dyspnea), a single item asking about financial difficulties, and global health status/quality of life (QOF) consisting of 2 items. Functional and symptoms scales were measured on a four-point Likert scale, where 1 = not at all and 4 = very much, whereas global health status or QOF was assessed using a 7-item Likert scale, ranging from "poor" (worse quality of life) to "excellent" (better quality of life). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA.

Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale

EQ-5D is comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score. The utility score measures mobility, self-care, usual activities, pain, discomfort, and anxiety/depression. Responses to each of the 5 health states are measured on a 3-point scale (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). The thermometer score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Changes from Baseline were analyzed by mixed model-repeated measures ANCOVA. A negative adjusted mean change from Baseline represents a worsening of quality of life.

Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points

Improvement is defined as a decrease from Baseline by at least one step on the ECOG performance status scale (improvement categorized as yes or no). Improvement in ECOG performance status was measured.

Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points

Participants with the indicated constitutional or B-symptoms (night sweats [without signs of infection]; unintentional weight loss >= 10% within the previous 6 months; recurrent, unexplained fever of > 38 degrees celcius or 100.5 degrees fahrenheit for 2 weeks; and extreme fatigue) were presented. The proportion of participants with no night sweats, no weight loss, no fever and no extreme fatigue were summarized.

Number of Participants With Grade 3 and Above Adverse Event of Infection

Participants with Grade 3, Grade 4 and Grade 5 adverse event of infection are presented. Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.0 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death).

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.

Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points

Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Number of participants who reported myelosuppression (anemia [low hemoglobin count], neutropenia [low neutrophil count], and thrombocytopenia [low platelet count]) are presented. AEs were graded according to NCI common terminology criteria for adverse events (CTCAE) grade, version 4.0 (1, mild; 2, moderate; 3, severe; 4, life-threatening/disabling; 5, death).

Number of Participants Who Received at Least One Transfusion During the Study

Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.

Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)

AIHA is a disease where the body's immune system fails to recognize red blood cells as "self" and begins destroying these red blood cells. The number of participants diagnosed with AIHA are presented.

Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result

All serum samples for analysis of HAHA were first tested in a screening step; positive samples from the screening were further evaluated in a confirmation test. The confirmed positive samples were reported as HAHA positive and further evaluated in the titration test to obtain a titer of HAHA. A confirmed positive result at any time point means the participant is positive for HAHA.Results are reported as the number of participants positive for HAHA.

Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points

Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-baseline value minus the Baseline value.

Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit

MRD refers to small number of leukemic cells that remain in the participant during treatment or after treatment at the time the participant achieved a confirmed complete remission. Number of participants who were positive and negative for minimal residual disease (MRD) at any visit is presented.

Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points

CD5+CD19+ cells were counted by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1 Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers

Blood samples were collected for the assessment of the following prognostic markers at Baseline (BL) and upon relapse: immunoglobulin heavy chain variable region (IgVH) mutational status; VH3-21 usage; Cytogenetics (by fluorescent in situ hybridization [FISH]) including 6q-, 11q-, +12q, 17p-, 13q- deletions; beta 2 microglobulin. Cox-regression model was used to explore the relationship between progression-free survival and the following explanatory variables: treatment group, cytogenetics (analyzed by FISH) at BL, IgVH mutational status at BL, beta 2 microglobulin at BL, BL CD20 and BL complement level. For each covariate, a hazard ratio <1 indicates a lower risk on the first effect tested compared with the other effects tested. Cytogenetics Group (based on >=20%)=CY G.

Cmax and Ctrough of Ofatumumab

Blood samples were collected to assess the plasma concentration of ofatumumab. Maximum concentration (Cmax) and observed drug concentration prior to the next dose (Ctrough) were determined. Blood samples were collected at pre-dose and 0.5 hours after the end of the infusion at treatment on Month 1 Week 1 (Day 1), Month 1 Week 2 (Day 8), and at every second infusion.

Total Plasma Clearance (CL) of Ofatumumab

Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.

AUC(0-tau) of Ofatumumab

Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of the drug exposure over time.

Vss of Ofatumumab

Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of a drug between plasma and the rest of the body at steady state. Data from all time points collected were used to calculate one Vss value for each individual.

Plasma Half-life (t1/2) of Ofatumumab

The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.

Full Information

NCT ID

NCT01039376

First Posted

December 23, 2009

Last Updated

July 16, 2019

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01039376

Brief Title

Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy

Acronym

PROLONG

Official Title

A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision

Study Start Date

May 6, 2010 (Actual)

Primary Completion Date

February 20, 2017 (Actual)

Study Completion Date

June 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.

Detailed Description

The study met its primary objective at the protocol defined interim analysis (data cut-off 19-Jun-2014). The protocol-defined final analysis of the primary endpoint was performed when 280 PFS events were reached (data cut-off 20-Feb-2017).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukaemia, Lymphocytic, Chronic

Keywords

maintenance therapy, anti-CD20 monoclonal antibody, ofatumumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

None (Open Label)

Allocation

Randomized

Enrollment

480 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM A: Ofatumumab

Arm Type

Experimental

Arm Description

300 mg IV Week 1 followed by 1000 mg IV Week 2 1000 mg IV (a dose every 8 weeks for up to 2 years following the first 1000 mg dose)

Arm Title

ARM B: Observation and assessments as per Arm A

Arm Type

Other

Arm Description

Disease status assessments to determine subject response or progression performed approximately every 8 weeks for up to 2 years for both arms according to IWCLL criteria

Intervention Type

Biological

Intervention Name(s)

Ofatumumab

Intervention Description

Ofatumumab for maintenance therapy as IV infusions every 8 weeks . The first dose was 300 mg followed 1 week later by 1000 mg and 1000 mg every 8 weeks thereafter for up to 2 years.

Intervention Type

Other

Intervention Name(s)

Observation

Intervention Description

Observation/Safety Evaluation

Primary Outcome Measure Information:

Title

Progression-free Survival, as Assessed by the Investigator

Description

Time Frame

From randomization until progression or death (up to 79 months)

Title

Progression-free Survival, as Assessed by the Independent Review Committee (IRC)

Description

Time Frame

From randomization until progression or death (up to 79 months)

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival is defined as time from randomization to date of death.

Time Frame

From randomization until death (up to 88 months)

Title

Number of Participants With Improvement in Response From Baseline

Description

Improvement in response was assessed by calculating the percentage of participants who changed from partial response (PR) at Baseline to complete response during the study.

Time Frame

From Baseline until the end of the study (up to 88 months)

Title

Time to Next Therapy

Description

Time to next therapy is defined as the time from randomization to the date of receiving the next CLL treatment.

Time Frame

From randomization until the end of the study (up to 88 months)

Title

Progression-free Survival After Next-line Therapy

Description

Time Frame

From randomization until progression or death (up to 88 months)

Title

Time to Progression After Next-line Therapy

Description

Time Frame

From randomization until progression or death (up to 88 months)

Title

Change From Baseline (BL) in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Chronic Lymphocytic Leukaemia 16 Item Module (EORTC QLQ-CLL 16)

Description

Time Frame

From randomization until the end of the study (up to 47 months)

Title

Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score

Description

Time Frame

From randomization until the end of the study (up to 47 months)

Title

Change From Baseline in the Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale

Description

Time Frame

From screening until the end of the study (up to 47 months)

Title

Number of Participants With an Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status at the Indicated Time Points

Description

Time Frame

From randomization until the end of the study (up to 88 months)

Title

Number of Participants With the Indicated Constitutional or B-symptoms at the Indicated Time Points

Description

Time Frame

From Screening until the end of the study (up to 88 months)

Title

Number of Participants With Grade 3 and Above Adverse Event of Infection

Description

Time Frame

From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 (up to 26 months)

Title

Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)

Description

Time Frame

From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until end of study for SAEs (88 months)

Title

Number of Participants With a Grade 3 or Grade 4 Myelosuppression (Anemia, Neutropenia, or Thrombocytopenia) at Indicated Time Points

Description

Time Frame

From first dose of study medication until 60 days after the last dose of study medication or until the last observation at Visit 14 for AEs (up to 26 months) and until the end of the study for SAEs (88 months)

Title

Number of Participants Who Received at Least One Transfusion During the Study

Description

Participants who received at least one transfusion (any blood products or blood supportive care product) during the study are presented.

Time Frame

From randomization until the end of the study (up to 88 months)

Title

Number of Participants Diagnosed With Autoimmune Hemolytic Anemia (AIHA)

Description

Time Frame

From randomization until the end of the study (up to 88 months)

Title

Number of Participants With a Positive Anti-ofatumumab Antibody (Human Anti-human Antibody; HAHA) Result

Description

Time Frame

Pre-dose (Visit 1), Months 7, 13, 19, and 25 during treatment and at 3 and 6 months after last ofatumumab dose (up to 30 months)

Title

Mean Change From Baseline in the Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM at Indicated Time Points

Description

Time Frame

Baseline, every six months during treatment, and after last treatment visit and/or upon relapse (up to 88 months)

Title

Number of Participants Who Were Positive and Negative for Minimal Residual Disease (MRD) at Any Visit

Description

Time Frame

From randomization until the end of the study (up to 88 months)

Title

Change From Baseline in Cluster of Differentiation (CD) CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points

Description

Time Frame

Baseline and every two months from Month 3 until Month 25 and at every followup (up to 88 months)

Title

Summary of Covariates to Compute Cox Proportional Hazards Regression Model for Relationship Between Investigator Assessed Progression-free Survival and the Indicated Prognostic Markers

Description

Time Frame

From Baseline until the end of the study (up to 79 months)

Title

Cmax and Ctrough of Ofatumumab

Description

Time Frame

Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

Title

Total Plasma Clearance (CL) of Ofatumumab

Description

Plasma clearance is defined as the plasma volume that is cleared of drug per unit of time.

Time Frame

Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

Title

AUC(0-tau) of Ofatumumab

Description

Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of the drug exposure over time.

Time Frame

Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

Title

Vss of Ofatumumab

Description

Time Frame

Day 1 Month 1 ( Cycle 1) through Month 7 ( Cycle 4)

Title

Plasma Half-life (t1/2) of Ofatumumab

Description

The terminal half life (t1/2) of ofatumumab is defined as the time required for the plasma concentration of ofatumumab to reach half of its original value.

Time Frame

Day 1 of Month 1 (Cycle 1 Week 1); Day 8 of Month 1 (Cycle 1 Week 2); and Month 7 (Cycle 4)

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults with documented diagnosis of CLL based on the modified IWCLL updated NCI-WG guidelines (Hallek, 2008) At least PR according to the revised 2008 NCI-WG CLL criteria, within 3 months of the response assessment after the last dose of 2nd/3rd line treatment The anti-leukemic treatment before study entry should have been at least 3 months or 3 cycles ECOG Performance Status of 0-2 Signed written informed consent prior to performing any study-specific procedures Exclusion Criteria: Known primary or secondary fludarabine-refractory subjects, defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months Prior maintenance therapy Known transformation of CLL (eg.Richter's transformation), prolymphocytic leukemia (PLL), or CNS involvement of CLL Active Autoimmune hemolytic anemia (AIHA) requiring treatment except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data Previous autologous or allogeneic stem cell transplantation Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis B or C Other past or current malignancy (with the exception of basal cell carcinoma or the skin or in situ carcinoma of the cervix or breasts) unless the tumor was successfully treated with curative intent at least 2 years prior to trial entry except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of exta systoles or minor conduction abnormalities except if in the opinion of the investigator and medical monitor it is thought not to affect the subject's safety, the conduct of the study or the interpretation of the data History of significant cerebrovascular disease or event with symptoms or sequelae Significant concurrent, uncontrolled medical condition that in the opinion of the investigator or GSK medical monitor contraindicates participation in this study Other anti-leukemic use of medications including glucocorticoids Known HIV positive Screening laboratory values: platelets <50 x 10x9/L, neutrophils<1.0 x 10x9/L, Creatinine > 1.5 X upper normal limit (unless normal creatinine clearance), total bilirubin >1.5 X upper normal limit, ALT >2.5 X upper normal limit (unless due to liver involvement of CLL), alkaline phosphase > 2.5 X upper normal limit Known or suspected hypersensitivity to ofatumumab that in the opinion of the investigator or medical monitor contraindicates study participation Subjects who have received treatment with any non-marketed drug substance or experimental therapy within 5-terminal half-lives or 4 weeks whichever is longer prior to first dose of study medication or currently participating in any other interventional clinical study Lactating women, women with a positive pregnancy test at Visit 1 or women (of childbearing potential) as well as men with partners of childbearing potential, who are not willing to use adequate contraception from study start through one year following last ofatumumab dose. Adequate contraception is defined as abstinence, oral hormonal birth control, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is sole partner for that subject. For females in the USA, the use of a double barrier method is also considered adequate (condom or occlusive cap plus spermicidal agent).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

Novartis Investigative Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Novartis Investigative Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Novartis Investigative Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Novartis Investigative Site

City

Berkeley

State/Province

California

ZIP/Postal Code

94704

Country

United States

Facility Name

Novartis Investigative Site

City

La Verne

State/Province

California

ZIP/Postal Code

91750

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95815

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Novartis Investigative Site

City

San Pablo

State/Province

California

ZIP/Postal Code

94806

Country

United States

Facility Name

Novartis Investigative Site

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Novartis Investigative Site

City

Lake Worth

State/Province

Florida

ZIP/Postal Code

33461

Country

United States

Facility Name

Novartis Investigative Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Novartis Investigative Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

Novartis Investigative Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Novartis Investigative Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Novartis Investigative Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Novartis Investigative Site

City

Post Falls

State/Province

Idaho

ZIP/Postal Code

83854

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Novartis Investigative Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Novartis Investigative Site

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

Novartis Investigative Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Novartis Investigative Site

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Novartis Investigative Site

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21742

Country

United States

Facility Name

Novartis Investigative Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Novartis Investigative Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89014

Country

United States

Facility Name

Novartis Investigative Site

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

Novartis Investigative Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87110

Country

United States

Facility Name

Novartis Investigative Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

Novartis Investigative Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14621

Country

United States

Facility Name

Novartis Investigative Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7305

Country

United States

Facility Name

Novartis Investigative Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Novartis Investigative Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Novartis Investigative Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37916

Country

United States

Facility Name

Novartis Investigative Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Novartis Investigative Site

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Novartis Investigative Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1426ANZ

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

Novartis Investigative Site

City

Derqui, Pilar

State/Province

Buenos Aires

ZIP/Postal Code

B1629AHJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

B1900AXI

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

1114

Country

Argentina

Facility Name

Novartis Investigative Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

Novartis Investigative Site

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

Novartis Investigative Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Novartis Investigative Site

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Novartis Investigative Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Novartis Investigative Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

Novartis Investigative Site

City

Salvador

State/Province

Bahía

ZIP/Postal Code

41253-190

Country

Brazil

Facility Name

Novartis Investigative Site

City

Goiania - GO

State/Province

Goiás

ZIP/Postal Code

74605-020

Country

Brazil

Facility Name

Novartis Investigative Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Barretos

State/Province

São Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

01221-001

Country

Brazil

Facility Name

Novartis Investigative Site

City

Sao Paulo

State/Province

São Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Novartis Investigative Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2G 1G3

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

Novartis Investigative Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A1A1

Country

Canada

Facility Name

Novartis Investigative Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Novartis Investigative Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Hradec Kralove

Country

Czechia

Facility Name

Novartis Investigative Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Novartis Investigative Site

City

Pelhrimov

ZIP/Postal Code

393 38

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Novartis Investigative Site

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Novartis Investigative Site

City

Kobenhavn

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

Novartis Investigative Site

City

Jyvaskyla

ZIP/Postal Code

40620

Country

Finland

Facility Name

Novartis Investigative Site

City

Pori

ZIP/Postal Code

28500

Country

Finland

Facility Name

Novartis Investigative Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

Novartis Investigative Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novartis Investigative Site

City

Blois cedex

ZIP/Postal Code

41016

Country

France

Facility Name

Novartis Investigative Site

City

Caen cedex 5

ZIP/Postal Code

14076

Country

France

Facility Name

Novartis Investigative Site

City

Clermont-Ferrand Cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Novartis Investigative Site

City

Lille cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Novartis Investigative Site

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

Novartis Investigative Site

City

Mulhouse

ZIP/Postal Code

68070

Country

France

Facility Name

Novartis Investigative Site

City

Pessac cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Saint Pierre cedex

ZIP/Postal Code

97448

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg cedex

ZIP/Postal Code

67098

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Vandoeuvre-Les-Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Novartis Investigative Site

City

Athens,

ZIP/Postal Code

11 527

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Piraeus

ZIP/Postal Code

18537

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

564 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4012

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kecskemet

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Ahmedabad

ZIP/Postal Code

380009

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

ZIP/Postal Code

400 012

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

ZIP/Postal Code

400014

Country

India

Facility Name

Novartis Investigative Site

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

Novartis Investigative Site

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

31048

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91031

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Novartis Investigative Site

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach-Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel-Aviv

Country

Israel

Facility Name

Novartis Investigative Site

City

Zrifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Novartis Investigative Site

City

Modena

State/Province

Emilia-Romagna

ZIP/Postal Code

41124

Country

Italy

Facility Name

Novartis Investigative Site

City

Piacenza

State/Province

Emilia-Romagna

ZIP/Postal Code

29100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

State/Province

Piemonte

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56100

Country

Italy

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Amersfoort

ZIP/Postal Code

3813 TZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1091 AC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Blaricum

ZIP/Postal Code

1261 AN

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Breda

ZIP/Postal Code

4819 EV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Den Bosch

ZIP/Postal Code

5223 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Den Haag

ZIP/Postal Code

2545AA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Deventer

ZIP/Postal Code

7416 SE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Dordrecht

ZIP/Postal Code

3318 AT

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Enschede

ZIP/Postal Code

7511JX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Hoofddorp

ZIP/Postal Code

2134 TM

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3079 DZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Sittard-geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

0027

Country

Norway

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Novartis Investigative Site

City

Chorzow

ZIP/Postal Code

41-500

Country

Poland

Facility Name

Novartis Investigative Site

City

Slupsk

ZIP/Postal Code

76-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Szczecin

ZIP/Postal Code

71-252

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

53-439

Country

Poland

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Penza

ZIP/Postal Code

440071

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St'Petersburg

ZIP/Postal Code

191024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St'Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197 089

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Volgograd

ZIP/Postal Code

400138

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat (Barcelona)

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28031

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Novartis Investigative Site

City

Toledo

ZIP/Postal Code

45004

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Goteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Linkoping

ZIP/Postal Code

SE-581 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lulea

ZIP/Postal Code

SE-971 80

Country

Sweden

Facility Name

Novartis Investigative Site

City

Orebro

ZIP/Postal Code

SE-701 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE 171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06590

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

Country

Turkey

Facility Name

Novartis Investigative Site

City

Istanbul

ZIP/Postal Code

34093

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

Country

Turkey

Facility Name

Novartis Investigative Site

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Khmelnytskyi

ZIP/Postal Code

29000

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

03022

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Lviv

ZIP/Postal Code

79044

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Makiivka

ZIP/Postal Code

86132

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Vinnitsa

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

IPD Sharing URL

https://www.clinicalstudydatarequest.com

Learn more about this trial

Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy

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Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy (PROLONG)

Leukaemia, Lymphocytic, Chronic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial